MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MULTIHOLE W/GRIPTION 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121730048
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Fall (1848); Inadequate Osseointegration (2646); Not Applicable (3189)
Date of Event	05/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Der stated that the patient fell.Ripped out the acetabular cup.It was also reported that the cup and stem were loosened at the bone to implant interface.Doi: (b)(6) 2018; dor: (b)(6) 2018; right hip.
Additional Manufacturer Narrative
(b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN MULTIHOLE W/GRIPTION 48MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7565686
• Report Number: 1818910-2018-61242
• Device Sequence Number: 2527076
• Product Code: LPH
• UDI-Device Identifier: 10603295009962
• UDI-Public: 10603295009962
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K071784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 121730048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR